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Background: Health apps are a booming, yet under-regulated market, with potential consumer harms in privacy and health safety. Regulation of the health app market tends to be siloed, with no single sector holding comprehensive oversight. We sought to explore this phenomenon by critically analysing how the problem of health app regulation is being presented and addressed in the policy arena. Methods: We conducted a critical, qualitative case study of regulation of the Australian mental health app market. We purposively sampled influential policies from government, industry and non-profit organisations that provided oversight of app development, distribution or selection for use. We used Bacchi's critical, theoretical approach to policy analysis, analysing policy solutions in relation to the ways the underlying problem was presented and discussed. We analysed the ways that policies characterised key stakeholder groups and the rationale policy authors provided for various mechanisms of health app oversight. Results: We identified and analysed 29 policies from Australia and beyond, spanning 5 sectors: medical device, privacy, advertising, finance, and digital content. Policy authors predominantly framed the problem as potential loss of commercial reputations and profits, rather than consumer protection. Policy solutions assigned main responsibility for app oversight to the public, with a heavy onus on consumers to select safe and high-quality apps. Commercial actors, including powerful app distributors and commercial third parties were rarely subjects of policy initiatives, despite having considerable power to affect app user outcomes. Conclusion: A stronger regulatory focus on app distributors and commercial partners may improve consumer privacy and safety. Policy-makers in different sectors should work together to develop an overarching regulatory framework for health apps, with a focus on consumer protection. [ABSTRACT FROM AUTHOR]

The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. Given the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling., (© 2022. The Author(s).)

Background: Weak governance over public sector pharmaceutical policy and practice limits access to essential medicines, inflates pharmaceutical prices, and wastes scarce health system resources. Pharmaceutical systems are technically complex and involve extensive interactions between the private and public sectors. For members of public sector pharmaceutical committees, relationships with the private sector can result in conflicts of interest, which may introduce commercial biases into decision-making, potentially compromising public health objectives and health system sustainability. We conducted a descriptive, qualitative study of conflict of interest policies and practices in the public pharmaceutical sector in ten countries in the World Health Organization (WHO) South-East Asia Region (SEAR) (Bangladesh, Bhutan, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand, and Timor-Leste) between September 2020 and March 2021., Results: We identified 45 policy and regulatory documents and triangulated documentary data with 21 expert interviews. Key informants articulated very different governance priorities and conflict of interest concerns depending on the features of their country's pharmaceutical industry, market size, and national economic objectives related to the domestic pharmaceutical industry. Public sector pharmaceutical policies and regulations consistently contained provisions for pharmaceutical committee members to disclose relevant interests, but contained little detail about what should be declared, when, and how often, nor whether disclosures are evaluated and by whom. Processes for preventing or managing conflicts of interest were less well developed than those for disclosure except for a few key procurement processes. Where processes for managing conflicts of interest were specified, the dominant strategy was to recuse committee members with a conflict of interest from relevant work. Policies rarely specified that committee members should divest or otherwise be free from conflicts of interest., Conclusions: Robust processes for conflict of interest prevention and management could ensure the integrity of decision-making and build public trust in pharmaceutical processes to achieve public health objectives. Upstream approaches including supportive legislative frameworks, the creation of oversight bodies, and strengthening regulatory institutions can also contribute to building cultures of transparency, accountability, and trust., (© 2022. The Author(s).)

Declining public trust in government and expert advice is a public health priority, given its impact on vaccination uptake, adherence to guidelines and social cohesion. In the context of the COVID-19 Vaccine Task Force, conflicts of interest that can threaten public trust are handled primarily through disclosures. However, this places the onus on the public to discern the relevance, severity and impact of these conflicts and does little to address whose interests guide decision making. Alternatively, expert advisory committees should adopt more trustworthy strategies, including promoting independence from commercial and political interests., (Copyright © 2022 Longwoods Publishing.)

Background: Few studies have investigated the relationship between industry funding/conflicts of interest and authors' positions in opinion pieces on drug safety. Harmful effects of varenicline, a treatment for smoking cessation, have been highly contested., Objective: To examine the association between pharmaceutical industry funding/authors' financial conflicts of interest and position on varenicline in opinion articles, especially in relation to the minimization of harms; to assess whether opinion pieces on drug safety issues written by authors with conflicts of interest are more frequently cited in the news or social media., Design: Cross-sectional analysis., Participants: English language opinion pieces and narrative reviews about varenicline published between May 2006 and February 2019., Main Measures: Odds ratios and 95% confidence intervals; the Mann-Whitney two-sample statistic was used to test for differences in Altmetric scores, a measure of media attention., Key Results: Of the 221 included articles, 30.3% (67) disclosed the funding source and 62.9% (139) disclosed authors' conflicts of interest. Authors of opinion pieces on varenicline who reported financial ties to the pharmaceutical industry (as a conflict of interest or funding source) were more likely to minimise the cardiovascular and psychiatric risk of varenicline compared to those without conflicts of interest or industry funding (OR: 4.00; 95% CI: 1.32 to 12.16 for cardiovascular risk; OR: 8.51; 95% CI: 3.79 to 19.11 for psychiatric risk). These associations persisted in sensitivity analyses. No statistically significant difference in Altmetric score was found between articles with (mean 15.83, median 3) and without (mean 11.90, median 1) conflicts of interest, indicating similar media attention (p-value=0.11)., Conclusions: We found that authors with financial ties to drug companies were more likely to publish opinion pieces that minimised harms of varenicline. These results raise questions about journals' editorial policies to accept reviews of treatments from authors with financial relationships with manufacturers., (© 2021. The Author(s).)

Health guidelines aim to improve patient outcomes through the promotion of evidence-based practice. Yet, when a guideline's recommendations significantly differ from, or threaten the interests, values and preferred practices of end-users, organised and often very public resistance to guideline implementation may result. To explore this phenomenon, we theorise a case study consisting of the public discourse following the update to a primary care breast screening guideline in Canada in 2018. Informed by sociological perspectives on the professions and evidence-based medicine, this paper aims to explore: [1] why professional stakeholders form active resistances to the implementation of some clinical guidelines; and, [2] how professional values, perspectives, interests and/or experiences influence the stakeholders' stance. Current understandings have taken a reductive approach in conceptualising the exclusion of experts and their resistance as "conflict of interest." Rather, we suggest that resistance is the product of multiple areas of contention, stemming from tensions related to clinical and professional autonomy, medical jurisdiction, and the role of medical elites. We highlight considerations for future guideline development and implementation process changes to mitigate and resolve issues related to active resistance. These considerations include understanding resistance as a political strategy, increasing transparency of public input and coalition building as a part of the public response to active resistance., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Objectives: The aim of the study was to identify the range of issues labeled as "non-financial conflicts of interest" in biomedicine, articulate the associated concerns, and analyze the implications of defining these issues as conflicts of interest., Study Design and Setting: This was a qualitative study, triangulating data from three purposively sampled sources: (1) literature, (2) policies, and (3) interviews. Participants were corresponding authors of sampled literature (December 2017 to January 2019). A critical, interpretive approach served as the analytic strategy., Results: A total of 99 articles provided the sampling frame; we recruited 16 participants and sampled 20 policies. Participants labeled a wide range of personal attributes, social relationships, professional experiences, intellectual endeavors, and financial interests as "non-financial conflicts of interest." Despite a lack of consensus regarding the nature of the problem, many "non-financial" interests are currently subject to policy action. The term serves as ethical shorthand to describe the ways that (1) "strong beliefs," (2) "predetermined views," (3) experiences, and (4) relationships shape evidence-led processes., Conclusion: Expansion of the definition of conflict of interest to include non-financial interests may have unintended consequences, including exclusion of diverse perspectives. Problems labeled "non-financial conflicts of interest" should be defined in terms of what they are rather than what they are not (i.e., "non"-financial). We suggest instead, preventing financial conflicts of interest and ensuring inclusive and equitable representation within evidence-based processes., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and declare support from the Canadian Institutes of Health Research and National Health and Medical Research Council.

Conflicts of interest, stemming from relationships between health professionals and the pharmaceutical industry, remain a highly divisive and inflammatory issue in healthcare. Given that most jurisdictions rely on industry to self-regulate with respect to its interactions with health professionals, it is surprising that little research has explored industry leaders' understandings of conflicts of interest. Drawing from in-depth interviews with ten pharmaceutical industry leaders based in Australia, we explore the normalized and structural management of conflicts of interest within pharmaceutical companies. We contrast this with participants' unanimous belief that the antidote to conflicts of interest with health professionals were "informed consumers." It is, thus, unlikely that a self-regulatory approach will be successful in ensuring ethical interactions with health professionals. However, the pharmaceutical industry's routine and accepted practices for disclosing and managing employees' conflicts of interest could, paradoxically, serve as an excellent model for healthcare.

The "as-if" world of nursing is a well-constructed, institutionally preserved and defended myth that asserts clinicians who are "just nurses" do not make decisions in the absence of "doctor's orders." Drawing on data from an ethnography exploring the interactions between nurses and industry, we explore the finding that many nurses did not identify as "decision makers" and were mystified by the attention of sales representatives. Many nurses experienced marketing as benign as there was no "decision" to sway. Nursing must deconstruct the "as-if" nondecisional myth by confronting conflicts of interest and owning fully its rightful clinical and advocacy roles. www.advancesinnursingscience.com.

Background: The mainstay for addressing conflicts of interest in health care is disclosure of personal financial ties to industry. However, this approach fails to capture the complexity of industry interactions that are built into clinical practice. Further, the policy climate focuses on physicians and traditional pharmaceutical marketing., Objective: To describe industry activities targeted at registered nurses., Design: Qualitative, ethnographic study conducted from January 2012 to October 2014., Setting: Four acute care hospitals in a western U.S. city., Participants: A purposive sample of 72 participants with direct experience with industry, including staff nurses, administrators, and industry and supply chain professionals., Measurements: Fieldwork, including observations (102 hours), semistructured in-depth interviews (n = 51), focus groups (n = 4), and documents analysis., Results: Nurses' reported financial relationships with industry were similar to those reported by prescribers. However, nurses reported that their most significant interactions with industry occurred in daily practice. The current policy environment rendered these interactions invisible, leaving nurses with little guidance to ensure that the boundary between service and sales remained intact., Limitations: This study could not determine the frequency or prevalence of nurse-industry interactions. The sample is not representative., Conclusion: Nurse-industry interactions may be common and influential, but they remain invisible in the current policy climate. Although some aspects of these interactions may be beneficial, others may pose financial risks to hospitals or safety risks to patients. Disclosure strategies alone do not provide health professionals with adequate support to manage day-to-day interactions. Management of industry interactions must include guidance for nurses., Primary Funding Source: Agency for Healthcare Research and Quality; Canadian Institutes of Health Research; and University of California, San Francisco.